RINGLOC-X E1 H/W 50/32MM 23
Report
- Report Number
- 3002806535-2021-00277
- Event Type
- Injury
- Date Received
- June 30, 2021
- Report Date
- August 13, 2021
- Manufacturer
- BIOMET UK LTD.
- Product Code
- KWA
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4), THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2, B4, B5, G3, G6, H1, H2, H10. ADDITIONAL INFORMATION RECEIVED: REASON FOR REVISION: THE PATIENT EXPERIENCED SERIOUS PAIN WHILE WALKING FOR THE FIRST TIME DURING 2019, AND THEREFORE IT WAS DECIDED TO REVISE THE IMPLANT IN (B)(6) 2020. EXPLANT DATE: (B)(6) 2020 - EXACT DATE NOT KNOWN SINCE THE REVISION OPERATION TOOK PLACE IN ANOTHER HOSPITAL PATIENT DETAILS: DOB: 1943 , AGE: 77, ACTIVITY LEVEL NOT KNOWN AND WEIGHT NOT KNOWN. DOES THE AVAILABLE INFORMATION SUGGEST THE DEVICE/PRODUCT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY? NO. WAS THE MEDICAL INTERVENTION FOR CORRECTION OF AN INFECTION? NO. DOES THE AVAILABLE INFORMATION SUGGEST THE DEVICE/PRODUCT HAS MALFUNCTIONED OR FAILED TO PERFORM AS INTENDED? NO. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2021-00276-1. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. ONE FULL-PELVIS ANTEROPOSTERIOR (AP) RADIOGRAPH WAS PROVIDED WITH (B)(4), TAKEN AFTER PRIMARY SURGERY ON AN UNKNOWN DATE. THE FEMORAL STEM APPEARS APPROPRIATELY SIZED AND POSITIONED WITHIN THE FEMORAL CANAL. THE INCLINATION ANGLE OF THE ACETABULAR SHELL WAS MEASURED AND IT WAS FOUND TO BE 43.4 DEGREES, WHICH IS IN AGREEMENT WITH THE RECOMMENDATIONS OF THE EXCEED ABT SURGICAL TECHNIQUE THAT THE SHELL SHOULD BE POSITIONED WITH AN INCLINATION ANGLE OF 40 TO 45 DEGREES. THE CERAMIC HEAD APPEARS CENTRED WITHIN THE ACETABULAR LINER AND SHELL. PRE-REVISION RADIOGRAPHS ARE REQUIRED TO ASSESS WHETHER THE POSITIONING AND ALIGNMENT OF COMPONENTS CHANGED OVER TIME. THESE RADIOGRAPHS COULD NOT BE OBTAINED BECAUSE REVISION WAS CARRIED OUT IN A DIFFERENT HOSPITAL. IT IS REPORTED THAT THE PATIENT IS FEMALE AND WAS 77 AT THE TIME OF REVISION, OTHER INFORMATION (WEIGHT, ACTIVITY LEVEL) IS UNKNOWN. SHE EXPERIENCED SERIOUS PAIN WHILE WALKING FOR THE FIRST TIME DURING 2019, AND THEREFORE IT WAS DECIDED TO REVISE THE IMPLANT IN (B)(6) 2020. IT IS ALSO NOTED THAT THE SURGICAL TECHNIQUE WAS FOLLOWED DURING PRIMARY SURGERY AND THAT THE AVAILABLE INFORMATION DOES NOT SUGGEST THAT THE DEVICE HAS MALFUNCTIONED OR FAILED TO PERFORM AS INTENDED. THE MANUFACTURING HISTORY RECORDS (MHRS) OF THE REVISED BIOLOX DELTA HEAD AND E1 LINER, AND OF THE ASSOCIATED EXCEED ABT SHELL, HAVE BEEN CHECKED AND VERIFY THAT THE PARTS WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. THE INSTRUCTIONS FOR USE INCLUDED WITH THE CERAMIC HEAD AND E1 LINER PROVIDED THE FOLLOWING INFORMATION: WARNINGS: BIOMET JOINT REPLACEMENT PROSTHESES PROVIDE THE SURGEON WITH A MEANS OF REDUCING PAIN AND RESTORING FUNCTION FOR MANY PATIENTS. WHILE THESE DEVICES ARE GENERALLY SUCCESSFUL IN ATTAINING THESE GOALS, THEY CANNOT BE EXPECTED TO WITHSTAND THE ACTIVITY LEVELS AND LOADS OF NORMAL HEALTHY BONE AND JOINT TISSUE. PATIENT WARNINGS: POSTOPERATIVE CARE IS IMPORTANT. THE PATIENT MUST BE WARNED OF THE LIMITATIONS OF THE RECONSTRUCTION AND THE NEED FOR PROTECTION OF THE IMPLANTS FROM FULL WEIGHT BEARING OR LOAD BEARING UNTIL ADEQUATE FIXATION AND HEALING HAS OCCURRED. THE PATIENT IS TO BE CAUTIONED TO GOVERN ACTIVITIES, PROTECTING THE JOINT REPLACEMENT FROM UNREASONABLE STRESS CONDITIONS. POSSIBLE ADVERSE EFFECT: PAIN, SWELLING, OR THE ONSET OF A LIMP MAY OCCUR, REQUIRING FURTHER EVALUATION FROM AN ORTHOPAEDIC SURGEON. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED PATIENT¿S PAIN AND IMPLANT REVISION WITHOUT ADDITIONAL RADIOGRAPHS, PATIENT (BMI, ACTIVITY LEVELS, PRE-EXISTING CONDITIONS) AND SURGICAL INFORMATION, AND WITHOUT EXAMINATION OF THE REVISED COMPONENTS. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO OTHER SIMILAR COMPLAINTS IDENTIFIED FOR THE ITEM NUMBERS EP-053250 AND 650-0833. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2021-00276-2. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT: DEVICE DISCARDED.
IT WAS REPORTED A PATIENT UNDERWENT A HIP ARTHROPLASTY ON (B)(6), 2014. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION IN (B)(6) 2020 OF THE PROSTHESIS WITH EXCLUSIVE CHANGE OF FEMORAL HEAD AND POLYETHYLENE DUE TO PAIN.
IT WAS REPORTED A PATIENT UNDERWENT A HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION IN (B)(6) 2020 OF THE PROSTHESIS WITH EXCLUSIVE CHANGE OF FEMORAL HEAD AND POLYETHYLENE DUE TO PAIN.
(B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT HAS BEEN DISCARDED. CONCOMITANT PRODUCTS: MEDICAL PRODUCT: EXC ABT RNGLC-X SHELL PC 050MM, CATALOG #: 131350, LOT #: 3188135 ; MEDICAL PRODUCT: GTS STANDARD FMRL STEM SIZE -2, CATALOG #: PS129GM2, LOT #: 0000773450 . MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2021-00276. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED A PATIENT UNDERWENT A HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION IN (B)(6) 2020 OF THE PROSTHESIS WITH EXCLUSIVE CHANGE OF FEMORAL HEAD AND POLYETHYLENE DUE TO UNKNOWN REASONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 992280 | RINGLOC-X E1 H/W 50/32MM 23 | RINGLOC E1 LINERS | KWA | BIOMET UK LTD. | N/A | 3305884 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| R |